Sample Size for Agreement Studies on Quantitative Variables

We reviewed the statistical assessments of the agreement between two measurement methods of continuous variables together with their recent contributions about the sample size calculation based on the “two one side t-tests (TOST) extensions to the individual equivalence. We generalized a restricted...

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Main Authors: Bruno Mario Cesana, Paolo Antonelli
Format: Article
Language:English
Published: Milano University Press 2024-07-01
Series:Epidemiology, Biostatistics and Public Health
Subjects:
Online Access:https://riviste.unimi.it/index.php/ebph/article/view/23479
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author Bruno Mario Cesana
Paolo Antonelli
author_facet Bruno Mario Cesana
Paolo Antonelli
author_sort Bruno Mario Cesana
collection DOAJ
description We reviewed the statistical assessments of the agreement between two measurement methods of continuous variables together with their recent contributions about the sample size calculation based on the “two one side t-tests (TOST) extensions to the individual equivalence. We generalized a restricted null hypothesis that constitutes a particular case in finding the supremum of the probability of rejecting the equivalence under the null hypothesis (H0) and which, obviously, limits its applicability. Particularly, we devise and propose an exact procedure for calculating the sample sizes for individual equivalence, as an expression of the agreement between two measurement methods, by using a size a test (that is, with adequate control of Type I error), based on the non-central bivariate t distribution with correlation equal to 1 and to the related functions for calculating a and 1-b probabilities. Furthermore, our devised procedure allows to calculate the sample sizes by choosing between two most suitable formulations of the global parameters space of the null and alternative hypotheses; indeed, they are based on the portion of the distribution of the differences between the two measurement methods or on appropriately chosen agreement thresholds. Thereafter, we compared our theoretical results with the recently published proposals of the sample size calculation for the Bland and Altman agreement analysis by means also of simulation studies. Finally, a program written in the open-source R language to perform sample size calculations according to our procedure is available upon request.
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spelling doaj-art-733d167f879e44558ebe43a5c0c8292b2025-08-20T02:16:44ZengMilano University PressEpidemiology, Biostatistics and Public Health2282-09302024-07-0119110.54103/2282-0930/23479Sample Size for Agreement Studies on Quantitative VariablesBruno Mario Cesana0https://orcid.org/0000-0003-0980-4008Paolo Antonellihttps://orcid.org/0009-0004-4155-2642University of Brescia (retired) We reviewed the statistical assessments of the agreement between two measurement methods of continuous variables together with their recent contributions about the sample size calculation based on the “two one side t-tests (TOST) extensions to the individual equivalence. We generalized a restricted null hypothesis that constitutes a particular case in finding the supremum of the probability of rejecting the equivalence under the null hypothesis (H0) and which, obviously, limits its applicability. Particularly, we devise and propose an exact procedure for calculating the sample sizes for individual equivalence, as an expression of the agreement between two measurement methods, by using a size a test (that is, with adequate control of Type I error), based on the non-central bivariate t distribution with correlation equal to 1 and to the related functions for calculating a and 1-b probabilities. Furthermore, our devised procedure allows to calculate the sample sizes by choosing between two most suitable formulations of the global parameters space of the null and alternative hypotheses; indeed, they are based on the portion of the distribution of the differences between the two measurement methods or on appropriately chosen agreement thresholds. Thereafter, we compared our theoretical results with the recently published proposals of the sample size calculation for the Bland and Altman agreement analysis by means also of simulation studies. Finally, a program written in the open-source R language to perform sample size calculations according to our procedure is available upon request. https://riviste.unimi.it/index.php/ebph/article/view/23479Measurement Methods comparisonQuantitative variablesBland-Altman analysisSample size calculationIndividual equivalence
spellingShingle Bruno Mario Cesana
Paolo Antonelli
Sample Size for Agreement Studies on Quantitative Variables
Epidemiology, Biostatistics and Public Health
Measurement Methods comparison
Quantitative variables
Bland-Altman analysis
Sample size calculation
Individual equivalence
title Sample Size for Agreement Studies on Quantitative Variables
title_full Sample Size for Agreement Studies on Quantitative Variables
title_fullStr Sample Size for Agreement Studies on Quantitative Variables
title_full_unstemmed Sample Size for Agreement Studies on Quantitative Variables
title_short Sample Size for Agreement Studies on Quantitative Variables
title_sort sample size for agreement studies on quantitative variables
topic Measurement Methods comparison
Quantitative variables
Bland-Altman analysis
Sample size calculation
Individual equivalence
url https://riviste.unimi.it/index.php/ebph/article/view/23479
work_keys_str_mv AT brunomariocesana samplesizeforagreementstudiesonquantitativevariables
AT paoloantonelli samplesizeforagreementstudiesonquantitativevariables